Navigating the complex and ever-evolving regulatory landscape for medical devices can be daunting. Manufacturers, Certification Bodies, and Approved Bodies face constant challenges – from shifting compliance requirements to rigorous quality management demands. That’s where Peritus Regulatory Consulting Ltd steps in.
With nearly 30 years of industry experience led by Teresa Perry, Peritus offers expert guidance and practical solutions to help you achieve faster market access, seamless compliance, and long-term success. Our handpicked team brings over a century of collective expertise, delivering tailored support across every stage of your regulatory journey.
Our Key Services Include:
- Regulatory Consulting: Comprehensive support including regulatory strategy advice and technical file creation to keep you ahead of compliance demands.
- Quality Management Systems (QMS): Full implementation, gap analysis, internal audits, document control, and auditor training designed to streamline your processes while meeting ISO, MDSAP, UK, and EU standards.
- Certification and Approved Body Support: Specialized assistance for start-ups navigating accreditation, including expertise in ISO/IEC standards and UKAS audits.
- Technical Services: Creation and review of CE/UKCA technical documentation, 510(k) applications, and clinical evaluation reports backed by experienced collaborators.
- Additional Services: Legal consultancy for mergers and liability claims, process optimisation, project management, customer experience improvements, training, and regulatory compliance roles such as PRRC and UKRP.
At Peritus, we don’t just offer advice – we deliver results. Whether you’re launching a new device or enhancing your existing systems, we’re here to simplify complexity and help you succeed.
Explore our new website to learn more about how Peritus Regulatory Consulting Ltd can support your medical device journey. For any questions or to discuss your specific needs, please get in touch.
Contact us today and take the first step towards smoother approvals and greater peace of mind.